Regarding Controlled Access for MR Facilities and the Use of Signs, please be advised of the following:
According to the U. S. Department Of Health and Human Services
Center for Devices and Radiological Health Food and Drug Administration, the document entitled,
Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices
(issued November 14, 1998), Attachment B, Recommended User Instructions for a Magnetic Resonance
Diagnostic Device, section B. 5 Controlled Access Area states:
"The controlled access area should be labeled "Danger - High Magnetic Field" at all entries.
Operators should be warned by appropriate signs about the presence of magnetic fields and their
force and torque on magnetic materials, and that loose ferrous objects should be excluded.
Here's safety protection and final reminders for operators,
doctors, patients and hospital staff.
High-visibility red, black, and white exclusion signs
are virtually impossible to miss.
Two security signs mounted at an entrance to the magnet
room itself alert everyone who enters that loose metallic
objects may become dangerous projectiles.
Don't let your safety warnings get left behind the door. If your door opens against the wall, consider posting signs
on each side of the door. Make sure your warning signs are visible, whether the door is open or shut.
Source: FDA MAUDE Database Access Number: 371015 Report Type: Injury Date FDA Received: 12/12/2001
It was reported that, during the installation of a scanner, a drywall subcontractor was injured. Their finger
was caught between the steel electrical box, PT was in the process of installing, and the magnet steel. PT
had been waened about the hazards of working around an energized magnet and had ignored a posted sign.
Source: FDA MAUDE Database Access Number: M143702 Report Type: Serious Injury Date FDA Received: 09/23/1987
An MRI unit was in operation at the hospital. A PT was being scanned. Present in the control room were hospital employees and an employee of
manufacturer. A workman employee by a contractor of the hospital came in the control room to do some work in the magnet room. The operator
told the workman that he could not perform any work at the moment because a PT was being scanned. The workman left and went to the head
of the imaging department and got a key to the back door of the magnet room. On this back door was a warning in arabic, hebrew, and english that
there was a magnet in this room. The workman ignored the sign and entered the room. He had a magnetic tool which flew out of his hand, hit the back door of the magnet,
which is covered by copper mesh and plexiglass, and broke the plexiglass. A piece of the plexiglass cut the head of the PT who was being scanned.
The PT incurred a scalp laceration which was stitched and PT was released.
Photo courtesy of Radiological
Sciences Laboratory,
Richard M. Lucas Center for MRS/I,
Stanford University School of Medicine,
Department of Radiology Stanford, CA
Photo courtesy
of St. Mary's Warwick Hospital, Boonville, IN